A government expert committee bans the fixed dose combination (FDC) of drugs containing etodolac + paracetamol

New Delhi: The central government has banned the manufacture, sale and distribution of fixed dose combinations (FDCs) of Etodolac and Paracetamol with immediate onset, saying “there is no therapeutic justification for these medicines and they may pose risks to humans”.

The government’s expert committee has approved restricted use in humans of two FDC drugs, naproxen IP and antacids, under certain conditions. These drugs are painkillers.

Fixed-dose combination drugs or cocktail drugs are those that contain a combination of two or more active pharmaceutical ingredients (API) in a fixed ratio.

The ban on Etodolac + Paracetamol FDCs was notified in 2018 but was challenged by the drug makers in the Delhi High Court.

Following an order by the Delhi High Court, the central government’s Drugs Technical Advisory Board (DTAB) formed a sub-committee to examine the matter. It said the drug was “irrational” and recommended its ban in the public interest.

On January 25 of this year, the issue was discussed again at a DTAB meeting, which recommended banning its manufacture, sale and distribution for human use.

“Now, therefore, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of the fixed dose combination drug Etodolac + Paracetamol with immediate effect as the said drug has been found to have no therapeutic justification and may entail risks to human beings,” the government notification issued on August 12 seen by Mint said.

“This combination of etodolac and paracetamol has been completely banned. Both are painkillers and there does not seem to be any benefit in administering this combination together,” said one of the state drug regulators.

Meanwhile, the Central Government has restricted the manufacture, sale or distribution of FDC drug Naproxen IP 375 mg + Esomeprazole Magnesium Trihydrate IP 20 mg Capsules or Tablets and Naproxen IP 250/500 mg + Pantoprazole IP 20 mg Capsules or Hard Gelatin Tablets respectively subject to certain conditions.

These conditions include that naproxen must be in an enteric-coated form and that FDC must be indicated in adults for the symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, or in patients at risk of developing gastric or duodenal ulcers associated with nonsteroidal anti-inflammatory drugs (NSAIDs), or to reduce the risk of developing gastric and duodenal ulcers and according to treatment guidelines.

He noted that the bioequivalence of naproxen capsule or tablet IP 375 mg + esomeprazole magnesium trihydrate IP 20 mg will be demonstrated with the internationally available FDC of the innovator within one year.

He noted that these drugs likely pose risks to humans, although there are safer alternatives to such drugs.

However, bioequivalence of Naproxen IP 250/500 mg + Pantoprazole IP 20 mg hard gelatin capsules or tablets must be demonstrated with Naproxen and Pantoprazole separately, according to the standard package insert, within one year. Equivalence of efficacy and safety must be demonstrated with the FDC of the international innovator of Naproxen Esomeprazole for the indication, within one year.

“The government committee periodically reviews the use of the drug. Naproxen is a high-end drug and its antacid components will be allowed only for certain conditions,” said the official mentioned above.

The Union Ministry of Health and Family Welfare last year banned the human use of 14 fixed-dose combination drugs.

In 2016, the central government banned the manufacture, sale and distribution of 344 drug combinations after the government’s expert panel suggested that these drugs were being sold to patients without scientific data.